Understanding the Role of Doulas in Supporting People With PMADs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum
研究概览
简要总结
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.
详细描述
Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention. A subsection of 20 participants who receive care from doulas in the PMAD training will also be eligible to participate in a qualitative interview at 6 months postpartum. The interview guide will be developed based on prior research with doulas, the PI's current research exploring doula-care in Montana, and feedback from the CAB. Example questions are expected to include: "What were your experiences working with a doula?" "What would have made your experience better?" and "What worked and what didn't work?"
Interviewers will all be graduate students who have completed research methods courses and will be trained by the PI, who has extensive experience in conducting qualitative research and in conducting qualitative interviews.
The following procedures will be followed:
- Once participants have indicated that they are interested in participating in the study, the PI will contact them to set up a time to discuss the study with them, and if they are interested and meet eligibility criteria, enroll them in the study. Participants will be randomly assigned to either receive standard care from a doula, the doula PMAD intervention, or perinatal care as usual.
- Before enrollment in the study, participants will be provided with a copy of the consent form, and the information on the consent form will be read to the participants.
- Once the participants have provided informed consent, they will be given the pre-test survey via REDCap and will take the survey again at 1 month postpartum and 3 months postpartum.
- All participants will be connected to a doula and receive either care as usual from a doula or a doula trained in the intervention by the PI and will engage in care with them throughout their pregnancy, during childbirth, and for 3 months postpartum. The exact components of the doula care provided will be developed in aim 2 based on the findings of study 1.
- Participants will be provided compensation (in the form of a gift card) after the completion of each survey (pre-test, 1 month postpartum, 3 and 6 months postpartum).
- At the completion of the study, participants will be thanked for their time and participation. For those who agreed to do member checks, participants will be re-contacted after analysis for member checks.
Participants who are randomized into the intervention arm of the study will also be randomly selected to participate in cross-sectional, semi-structured interviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants must be over the age of 18
- •Currently pregnant and between 13 and 26 gestational weeks at the time of enrollment
- •Live in a HRSA-designated rural area of Montana
排除标准
- •They are under the age of 18
- •Not currently pregnant
- •Not between 13-26 gestational weeks at the time of enrollment
- •If they do not live in a HRSA-designated rural are of Montana.
研究组 & 干预措施
Standard Doula Care Plus the PMAD Intervention
Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training in addition to PMAD-specific care from their doulas.
干预措施: Standard Doula Care Plus PMAD Intervention (Behavioral)
Standard Doula Care
Participants in this arm will receive standard perinatal doula care provided by doulas trained in the DONA International doula training.
干预措施: Standard Doula Care (Behavioral)
Standard Maternal Care
In this arm participants will receive standard perinatal medical care and will not receive care from a doula.
结局指标
主要结局
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 1-month postpartum
时间窗: At 1-month postpartum
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 1 month postpartum
时间窗: 1-month postpartum
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
The General Self-Efficacy Scale (SGSE)
时间窗: At study enrollment
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the General Self-Efficacy Scale (SGSE) at 6-months postpartum
时间窗: At 6-months postpartum.
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 6 months postpartum
时间窗: At 6-months postpartum.
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in Edinburgh Depression Scale at 6-months postpartum
时间窗: At 6-months postpartum.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in Patient Health Questionnaire at 6-months postpartum (PHQ)-9
时间窗: At 6-months postpartum.
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Generalized Anxiety Disorder (GAD)-7
时间窗: At study enrollment
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
The Childbirth Self-Efficacy Inventory (CBSEI)
时间窗: At study enrollment
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in the Childbirth Self-Efficacy Inventory (CBSEI) at 3 months postpartum
时间窗: At 3-months
The Childbirth Self-Efficacy Inventory (CBSEI) is a 60-item self-report instrument that measures self-efficacy expectancies for coping with childbirth. In describing the development of the CBSEI, Lowe (1993) reports that the CBSEI scales have excellent internal consistency reliability (0.86 to 0.96) and factor analysis suggested that each CBSEl scale is unidimensional. Validity of the CBSEI was supported by significant positive correlations with the criterion variables of generalized self-efficacy, self-esteem, and internal health locus of control; and significant negative correlations with external health locus of control and learned helplessness. Validity was also supported by significantly higher self-efficacy scores for multiparous as compared to nulliparous pregnant women.
Change in the General Self-Efficacy Scale (SGSE) at 1-month postpartum
时间窗: 1-month postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Change in the General Self-Efficacy Scale (SGSE) at 3-months postpartum
时间窗: At 3-months postpartum
The General Self-Efficacy Scale (SGSE) is a 17-item self-report instrument that measures perceived self-efficacy. Internal consistency reliability for the SGSE scale in organizational research has been moderate to high (alpha = .76 to .89) (e.g., Cable \& Judge, 1994; Earley \& Lituchy, 1991; Gardner \& Pierce, 1998; Riggs \& Knight, 1994; Schaubroeck \& Merritt, 1997; Smith \& Foti, 1998).
Patient Health Questionnaire (PHQ)-9
时间窗: At study enrollment
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in Patient Health Questionnaire at 3-months postpartum (PHQ)-9
时间窗: At 3-months postpartum.
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in the Edinburgh Depression Scale at 3-months postpartum
时间窗: At 3-months postpartum.
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in Patient Health Questionnaire at 1-month postpartum (PHQ)-9
时间窗: At 1-month postpartum
The Patient Health Questionnaire (PHQ)-9 is a 9-item self-report instrument that measures depression. The PHQ-9 has high criterion validity (.88 sensitivity, .88 specificity) and reliability of .86-.89 (Kroenke et al., 2021).
Change in Generalized Anxiety Disorder (GAD)-7 at 3-months postpartum
时间窗: At 3-months postpartum.
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 3-months postpartum
时间窗: At 3-months postpartum.
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Change in Multi-Dimensional Scale of Perceived Social Support (MSPSS) at 6-months postpartum
时间窗: At 6-months postpartum.
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
Birth Companion Support Questionnaire
时间窗: 1-month postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Change in Social Support Questionnaire (SSQ)- Short Form at 1-month postpartum
时间窗: At 1-month postpartum
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Edinburgh Depression Scale
时间窗: At study enrollment
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in the Edinburgh Depression Scale at 1-month postpartum
时间窗: At 1-month postpartum
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report instrument that measures postnatal depression. A review of validation studies of the Edinburgh Depression Scale suggest the EPDS has high sensitivity and specificity (Eberhard-Gran et al., 2001). Other research supports its concurrent and predictive validity and Cronbach's alpha of between .82-.84 (Bergink et al., 2011).
Change in Social Support Questionnaire (SSQ)- Short Form at 6-months postpartum
时间窗: At 6-months postpartum.
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Birth Companion Support Questionnaire at 3-months postpartum
时间窗: At 3-months
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
Change in the Perceived Wellness Scale at 3-months postpartum
时间窗: 3-months postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in Generalized Anxiety Disorder (GAD)-7 at 1-month postpartum
时间窗: At 1-month postpartum
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Change in Generalized Anxiety Disorder (GAD)-7 at 6 months postpartum
时间窗: At 6-months postpartum.
The GAD-7 screens for and is a symptom severity measure for four of the most common anxiety disorders. Spitzer et al.,(2006) describe strong support of the GAD-7: "Studies with the GAD indicate that the internal consistency of the GAD-7 is excellent (Cronbach α = .92). Test-retest reliability is also good (intraclass correlation = 0.83). Comparison of scores derived from the self-report scales with those derived from the MHP-administered versions of the same scales yielded similar results (intraclass correlation = 0.83), indicating good procedural validity. As the cut point increases, sensitivity decreases and specificity increases in a continuous fashion. At a cut point of 10 or greater, sensitivity and specificity exceed 0.80, and sensitivity is nearly maximized. The GAD-7 also has strong construct validity. There is a strong association between increasing GAD-7 severity scores and worsening function on all 6 SF-20 scales."
Multi-Dimensional Scale of Perceived Social Support (MSPSS)
时间窗: At study enrollment
The MSPSS is a 12-item measure of perceived social support from three sources. Internal reliability of the MSPSS is strong using Cronbach's coefficient alphas (.91) (Dahlem et al., 1991).
The Perceived Wellness Scale
时间窗: At study enrollment
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the Perceived Wellness Scale at 1-month postpartum
时间窗: 1-month postpartum
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the Perceived Wellness Scale at 6-months postpartum
时间窗: At 6-months postpartum.
The perceived wellness scale is a 36-item measure designed to assess an individual's own perception of their wellness through physical, spiritual,intellectual, psychological, social and emotional dimensions. Research by Adams (1995) indicates the scale has high factorial, discriminant, convergent and face validity. It also had high consistency (a = .91), and test-retest reliability (r = .73 to .81) (Adams, 1995).
Change in the City Birth Trauma Scale at 3-months postpartum City Birth Trauma Scale
时间窗: At 3-months postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Social Support Questionnaire (SSQ)- Short Form
时间窗: At study enrollment
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Social Support Questionnaire (SSQ)- Short Form at 3-months postpartum
时间窗: At 3-months postpartum.
The SSQ-Short Form is a 6-item measure of social support that measures the number of people available to provide support in 6 different areas. The internal reliability of the short-version is high (.97-.98) (Sarason et al.,1987).
Change in Birth Companion Support Questionnaire at 6-months postpartum
时间窗: At 6-months postpartum
The BCSQ is comprised of 17-items to measure participants perception of lay birth companion support during labor. Research by Dunne et al., (2014) notes internal consistency (Cronbach's alpha is between .66-.76) and content and construct validity of the questionnaire (Dunne et al., 2014).
City Birth Trauma Scale City Birth Trauma Scale
时间窗: At 1-month postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
Change in the City Birth Trauma Scale at 6-months postpartum City Birth Trauma Scale
时间窗: At 6-months postpartum
The City Birth Trauma Scale is a 29-item questionnaire developed to measure birth-related PTSD according to DSM-5 criteria of: stressor criteria (A), symptoms of re-experiencing (B), avoidance (C), negative cognitions and mood (D), and hyperarousal (E), as well as duration of symptoms (F), significant distress or impairment (E), and exclusion criteria or other causes (H). It has a high alpha of .92 (Ayers et al., 2018).
次要结局
- Change in the Alcohol Use Disorders Identification Test (AUDIT) at 6-months postpartum Alcohol Use Disorders Identification Test (AUDIT)(At 6-months postpartum)
- Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 6-months postpartum(At 6-months postpartum)
- Change in the Alcohol Use Disorders Identification Test (AUDIT) at 1-month postpartum Alcohol Use Disorders Identification Test (AUDIT)(At 1-month postpartum)
- Alcohol Use Disorders Identification Test (AUDIT) Alcohol Use Disorders Identification Test (AUDIT)(At study enrollment)
- Change in the Alcohol Use Disorders Identification Test (AUDIT) at 3-months postpartum Alcohol Use Disorders Identification Test (AUDIT)(3-months postpartum)
- CDC Health-Related Quality of Life (HRQOL)- 4 scale(At study enrollment)
- Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 3-months postpartum(At 3-months postpartum.)
- Drug Abuse Screening Test (DAST)(At study enrollment)
- Pregnancy Risk Assessment Monitoring (PRAMS)(1 time during the study period, at 1-month postpartum.)
- Change in the Drug Abuse Screening Test (DAST) at 1-month postpartum(At 1-month postpartum)
- Change in the Drug Abuse Screening Test (DAST) at 3-months postpartum(At 3-months postpartum)
- Change in the Drug Abuse Screening Test (DAST) at 6-months postpartum(At 6-months postpartum.)
- Change in the CDC Health-Related Quality of Life (HRQOL)- 4 scale at 1-month postpartum(At 1-month postpartum)